{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-05",
    "results": {
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  "results": [
    {
      "pma_number": "P240028",
      "supplement_number": "S006",
      "applicant": "EBR Systems, Inc.",
      "street_1": "480 Oakmead Pkwy.",
      "street_2": "",
      "city": "Sunnyvale",
      "state": "CA",
      "zip": "94085",
      "zip_ext": "",
      "generic_name": "Leadless Cardiac Resynchronization Therapy (CRT)",
      "trade_name": "WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System",
      "product_code": "SEG",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2026-02-25",
      "decision_date": "2026-03-27",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "qualification of a new supplier for the IrOx coating process on the needle tip of the WiSE CRT System",
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        "device_name": "Leadless Cardiac Resynchronization Therapy (Crt)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
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}